Company ยท DE
Raumedic AG
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2025. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GWM | Device, Monitoring, Intracranial Pressure | 6 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 29, 2025 | K250285 | NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT- Raumedic AG, DE | GWM |
| Jul 6, 2017 | K171666 | MPR2 logO DATALOGGER Raumedic AG, DE | GWM |
| Oct 25, 2013 | K130529 | RAUMEDIC-PTO-MONITORING-SYSTEM Raumedic AG, DE | GWM |
| Apr 11, 2012 | K120252 | RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM Raumedic AG, DE | GWM |
| Oct 11, 2011 | K112017 | RAUMEDIC ICP MONITORING SYSTEM Raumedic AG, DE | GWM |
| Mar 4, 2011 | K103206 | RAUMEDIC- ICP-MONITORING SYSTEM Raumedic AG, DE | GWM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||